Post-Dural Puncture HeadacheUpSideDownNCT02427009
Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache
A study testing Prone position for 1 hour after blood patch and Blood patch in people with Post-Dural Puncture Headache, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to assess the rate of recurrence of headache following a first blood patch where patients will be positioned in the prone position for an hour after each blood patch needed during this study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- Prone position for 1 hour after blood patch and Blood patch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to 23 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient was informed about the implementation of the study, its objectives, constraints and patient rights
- The patient has signed the informed consent
- The patient must be affiliated or beneficiary of a health insurance plan
- The patient is available for follow up concerning her hospital stay
- The patient has a post-dural puncture headache after a vaginal delivery. The diagnosis of post-puncture headache is retained on the basis of a frankly postural character for the headache, triggered or exacerbated by orthostatic position and relieved by recumbency.
- The patient has an indication for a blood patch
Who cannot join
- The patient is participating in another interventional study, with the exception of the following studies: Papillo PMA (2013-A00538-37); DG-Postpartum (2013-A00277-38); ElastoMAP (2013-A01148-37); ElastoDéclench (2014-A00828-39); LXRs(2009-A00968-49); OASIS II (2013-A00773-42); GrossPath (2014-A01120-47).
- The patient is in an exclusion period determined by a previous study
- The patient is under guardianship, curatorship or under judicial protection
- The patient refuses to sign the consent
- It is not possible correctly inform the patient
- The patient is pregnant
- The patient has a contra-indication (or an incompatible combination therapy) for a necessary treatment in this study
- The patient was delivered by cesarean section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache
The main objective of this study is to assess the rate of recurrence of headache following a first blood patch where patients will be positioned in the prone position for an hour after each blood patch needed during this study.
Read the detailed description
The secondary objectives of this study are to:
- To evaluate the number of blood patches needed for each patient during her hospital stay B. Assessing the intensity of all headaches every 24H C. Evaluate the complications occurring during the hospital stay.
- Conditions
- Post-Dural Puncture Headache
- Being tested
- Prone position for 1 hour after blood patch, Blood patch
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone position for 1 hour after blood patchOther
After performing a blood patch, the patient will be placed in a prone position for 1 hour. This applies to all blood patches required during her hospitalization.
Blood patchProcedure or surgery
And indicated in inclusion criteria, patients in this protocol will have at least 1 blood patch. The amount of blood to be injected into the peridural space is fixed at 20 ml, but can be less in case of pain.
| Study group | Role | What they receive |
|---|---|---|
| The study population | Experimental | The study population consists of adult women requiring an epidural blood patch for the treatment of post-dural puncture headache following vaginal delivery. Women who delivered by cesarean section are not included due to the discomfort of the prone position while there is an abdominal scar.
Intervention: Prone position for 1 hour after blood patch Receives: Other: Prone position for 1 hour after blood patch; Procedure: Blood patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache recurrence: yes/no
Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
Measured: 24 hours after first blood patch
Headache recurrence: yes/no
Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
Measured: 48 hours after first blood patch
Headache recurrence: yes/no
Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
Measured: 72 hours after first blood patch
Secondary outcomes (7)
The number of blood patches required for each patient
Measured: Hospital discharge (expected average of 7 days)
Visual analog scale for pain
Scale from 0.0 to 10.0.
Measured: Baseline (day 0)
Visual analog scale for pain
Scale from 0.0 to 10.0.
Measured: 24 hours after blood patch
Visual analog scale for pain
Scale from 0.0 to 10.0.
Measured: 48 hours after blood patch
Visual analog scale for pain
Scale from 0.0 to 10.0.
Measured: 72 hours after blood patch
Presence/absence of complications
Presence / absence of the following complications: nerve paresthesia; nerve damage; accidental dural puncture; subcutaneous hematoma at the puncture site; meningitis; epidural abscess; localized infection at the puncture site; encephalopathy; cerebral venous thrombosis; subdural hematoma
Measured: During hospital stay (expected average of 7 days)
In case of recurrence of headache following the 1st blood patch, the presence / absence of the following accompanying symptoms: nausea; vomiting; dizziness; tinnitus; diplopia; photophobia; low back pain.
Measured: During hospital stay (expected average of 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startDec 2015
- Primary completion21 Apr 2016
- Study completion23 Apr 2016
Why it stopped: no inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy Aya, MD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427009
- Sponsor's protocol ID
- LOCAL/2015/GA-01
- Other IDs
- 2014-A01921-46
- Acronym
- UpSideDown
- Status last verified
- Jan 2017
- First submitted
- 20 Apr 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache
- ClinicalTrials.gov ID
- NCT02427009
- Acronym / sponsor ID
- UpSideDown / LOCAL/2015/GA-01
- Conditions
- Post-Dural Puncture Headache
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no inclusion
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 21 Apr 2016 (actual)
- Study completion
- 23 Apr 2016 (actual)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to assess the rate of recurrence of headache following a first blood patch where patients will be positioned in the prone position for an hour after each blood patch needed during this study.
Detailed description
The secondary objectives of this study are to:
- To evaluate the number of blood patches needed for each patient during her hospital stay B. Assessing the intensity of all headaches every 24H C. Evaluate the complications occurring during the hospital stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | Experimental | Other: Prone position for 1 hour after blood patch, Procedure: Blood patchThe study population consists of adult women requiring an epidural blood patch for the treatment of post-dural puncture headache following vaginal delivery. Women who delivered by cesarean section are not included due to the discomfort of the prone position while there is an abdominal scar. Intervention: Prone position for 1 hour after blood patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient was informed about the implementation of the study, its objectives, constraints and patient rights
- The patient has signed the informed consent
- The patient must be affiliated or beneficiary of a health insurance plan
- The patient is available for follow up concerning her hospital stay
- The patient has a post-dural puncture headache after a vaginal delivery. The diagnosis of post-puncture headache is retained on the basis of a frankly postural character for the headache, triggered or exacerbated by orthostatic position and relieved by recumbency.
Key exclusion criteria (8 listed)
- The patient is participating in another interventional study, with the exception of the following studies: Papillo PMA (2013-A00538-37); DG-Postpartum (2013-A00277-38); ElastoMAP (2013-A01148-37); ElastoDéclench (2014-A00828-39); LXRs(2009-A00968-49); OASIS II (2013-A00773-42); GrossPath (2014-A01120-47).
- The patient is in an exclusion period determined by a previous study
- The patient is under guardianship, curatorship or under judicial protection
- The patient refuses to sign the consent
- It is not possible correctly inform the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone position for 1 hour after blood patchAfter performing a blood patch, the patient will be placed in a prone position for 1 hour. This applies to all blood patches required during her hospitalization. | Other | The study population |
| Blood patchAnd indicated in inclusion criteria, patients in this protocol will have at least 1 blood patch. The amount of blood to be injected into the peridural space is fixed at 20 ml, but can be less in case of pain. | Procedure or surgery | The study population |
Primary outcome
Headache recurrence: yes/no
Time frame: 24 hours after first blood patch
Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
Headache recurrence: yes/no
Time frame: 48 hours after first blood patch
Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
Headache recurrence: yes/no
Time frame: 72 hours after first blood patch
Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
7 secondary outcomes
The number of blood patches required for each patient
Time frame: Hospital discharge (expected average of 7 days)
Visual analog scale for pain
Time frame: Baseline (day 0)
Visual analog scale for pain
Time frame: 24 hours after blood patch
Visual analog scale for pain
Time frame: 48 hours after blood patch
Visual analog scale for pain
Time frame: 72 hours after blood patch
Presence/absence of complications
Time frame: During hospital stay (expected average of 7 days)
In case of recurrence of headache following the 1st blood patch, the presence / absence of the following accompanying symptoms: nausea; vomiting; dizziness; tinnitus; diplopia; photophobia; low back pain.
Time frame: During hospital stay (expected average of 7 days)
Results and safety
The study was stopped early (reason given: no inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Aya, MD study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone position for 1 hour after blood patch and Blood patch in people with Post-Dural Puncture Headache, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache recurrence: yes/no (time frame: 24 hours after first blood patch). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.